The US Food and Drug Administration (FDA) approved doxorubicin hydrochloride liposome injection (Sun Pharma Global FZE) for the treatment of patients with ovarian cancer with disease progression after platinum-based chemotherapy and for the treatment of AIDS-related sarcoma in patients after failure of systemic chemotherapy or intolerance to that therapy. Approval for doxorubicin hydrochloride liposome injection was granted on February 4, 2013.
The review of this generic application was expedited by the FDA’s Office of Generic Drugs because of the continuing drug shortage of Doxil Injection (doxorubicin hydrochloride liposome; Janssen Products, LP). Doxil is under shortage because of manufacturing issues. To meet patient needs, the FDA exercised its regulatory discretion with regard to alternative doxorubicin hydrochloride liposome products.